3D Printed Medical Devices Regulatory Approaches
26th Jul 17
The approach of the Therapeutic Goods Administration (TGA) to the regulation of 3D printed medical devices is the focus of a high-level discussion to be held in Melbourne on 10 August 2017.
Key Issues For The Dental Industry —
The increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory frameworks to mitigate risks to patients, and to meet requirements for health care providers and manufacturers. The widespread application of this manufacturing technology to medical devices was not envisioned more than a decade ago when the TGA introduced its regulatory framework for medical devices.
Australia, and other jurisdictions, introduced exemption provisions for regulating custom-made medical devices with the intention to cover special cases where commercially available mass produced products were inadequate for the needs and requirements of a particular patient. The provisions were based on the premise that affected devices would largely comprise low risk products such as glass eyes, prosthetic limbs, prescription lenses, dental crowns, etc. This assumption regarding risk classification was accurate at the time the current custom-made medical device provisions were introduced, but the situation has evolved.
High risk implantable devices are generally manufactured under strictly controlled conditions and are subject to rigorous premarket testing and regulatory oversight to ensure that they comply with the essential principles for safety and performance. However, strict regulatory oversight is not the case with the majority of similarly high risk 3D printed implants in Australia, which are currently captured under exemptions for custom-made medical devices.
The TGA has invited the Australian Dental Industry Association (ADIA), as the peak business organisation representing dental product manufacturers and suppliers, to support reviews assessing the adequacy of the current regulatory framework in Australia for 3D printed medical devices. The major focus of these discussions will be to consider potential reforms to address potential gaps in the regulatory framework. ADIA's discussions with the TGA will be made in the context of the approved policy as set out below:
The dental industry’s contribution to the TGA’s discussions will be primarily undertaken by the ADIA-LIG Laboratory Interest Group, the forum for members in the dental laboratory sector to come together and share experiences then explore ideas about how to best support the sector. ADIA’s policy advocacy in this area is augmented by the work of members serving on the ADIA-PRPC Product Regulation Policy Committee. If you have an interest in this work, get involved today.
In actively lobbying for reform of the regulatory framework for 3D printed dental products, ADIA is working towards a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.
Member Engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to to matters associated with the dental laboratory sector, ADIA staff responsible for negotiating policy outcomes with government receive advice and guidance from members serving on ADIA-LIG Laboratory Interest Group and also the ADIA-PRPC Product Regulation Policy Committee. Updates are provided at the quarterly series of ADIA State Branch Briefings.
Further Information —
If you have an interest in ADIA's efforts to reform the regulatory standards for equipment installation, for updates subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at email@example.com or by telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 26 July 2017 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
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9th Oct 17
The TGA is proposing that dental product manufacturers provide an information card when supplying a implantable medical device as an outcome of alignment of Australia's medical device regulations with that of the European Union.
26th Sep 17
The Australian Dental Industry Red Tape Index the fourth quarter of FY2016-17 jumped significantly to 58.7, indicating a moderate increase in regulatory compliance costs for the businesses that manufacture and supply dental products.